Cleared Traditional

K982501 - ELECTROLYTE BUFFER A443-325

K982501 is the FDA 510(k) clearance for ELECTROLYTE BUFFER A443-325 by Alko Diagnostic Corp.. It is a Class 2 Chemistry device (product code JIX) cleared through the Traditional 510(k) pathway after a 43-day FDA review.

K982501 · Alko Diagnostic Corp. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1998
Decision
43d
Days
Class 2
Risk

K982501 is an FDA 510(k) clearance for the ELECTROLYTE BUFFER A443-325, ELECTROLYTE REFERENCE REAGENT A443-315, CO2 ACI.... Classified as Calibrator, Multi-analyte Mixture (product code JIX), Class II - Special Controls.

Submitted by Alko Diagnostic Corp. (Holliston, US). The FDA issued a Cleared decision on September 1, 1998 after a review of 43 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1150 - the FDA in vitro diagnostics and chemistry framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Alko Diagnostic Corp. devices

Submission Details

510(k) Number K982501 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 20, 1998
Decision Date September 01, 1998
Days to Decision 43 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
45d faster than avg
Panel avg: 88d · This submission: 43d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JIX Calibrator, Multi-analyte Mixture
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1150
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Chemistry devices follow this clearance model.

Regulatory Peers - JIX Calibrator, Multi-analyte Mixture

All 202
Devices cleared under the same product code (JIX) and FDA review panel - the closest regulatory comparables to K982501.
MODIFICATION OF PRECISET SERUM PROTEINS CALIBRATOR
K984425 · Boehringer Mannheim Corp. · Jan 1999
SYNCHRON SYSTEMS ENZYME VALIDATOR SET LEVELS 1 AND 2
K984014 · Beckman Coulter, Inc. · Dec 1998
PRECISET SERUM PROTEINS CALIBRATOR
K983469 · Boehringer Mannheim Corp. · Nov 1998
AMM CAL, BIL CAL, CO2 CAL, HDL CAL, IRON/MG CAL, LDL CAL, MC CAL, UPRO CAL, AND ISE CALIBRATOR LEVELS 1 AND 2
K981706 · Abbott Laboratories · Jul 1998
OLYMPUS SERUM PROTEIN MULTICALIBRATOR
K981305 · Olympus America, Inc. · May 1998
DOCUMENT AMMONIA/ETHANOL/LACTATE CALIBRATOR, PN: M-109
K981436 · Casco Standards · Apr 1998